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Obstetric & Pediatric Evolution Following Parental Refusal for Early Termination of Pregnancy Despite Fetal Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393455
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies.

In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.


Condition or disease Intervention/treatment
Termination of Pregnancy Other: not accurate

Study Design
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Study Type : Observational
Actual Enrollment : 211 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Evolution of Maternal & Infantile Health Following Parental Refusal of Termination of Pregnancy Despite Such Option Being Allowable by the Centre Pluridisciplinary de Diagnostic Prenatal (Interdisciplinary Center for Prenatal Diagnostics)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Intervention Details:
  • Other: not accurate
    not accurate

Outcome Measures
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Primary Outcome Measures :
  1. Apgar score at 5 minutes [ Time Frame: 1 day ]
    Apgar score at 5 minutes


Secondary Outcome Measures :
  1. health status of children [ Time Frame: 1 day ]
    health status of children at 1 year old : alive or dead.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mother and child after refusal of termination of pregnancy despite serious fetal pathology
Criteria

Inclusion criteria:

- refusal of termination of pregnancy despite serious fetal pathology

Exclusion criteria:

  • termination of pregnancy
  • termination of pregnancy not accepted by the Interdisciplinary Center for Prenatal Diagnostics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393455


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: florent FUCHS University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03393455    
Other Study ID Numbers: RECHMPL17_0260
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Fetal pathology
Obstetrical outcome
Pediatric outcome